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NCT Number: NCT07198321

A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study of GFH276 in Patients With RAS-Mutant Advanced Solid Tumors

This study is an investigation to evaluate the safety/tolerability, pharmacokinetics (PK), and efficacy of GFH276 as a single agent in patients with advanced solid tumors harboring RAS mutations.

The primary objectives of the Phase I study are to assess the safety/tolerability, PK, and preliminary efficacy of GFH276 in patients with advanced solid tumors harboring RAS mutations, and to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of GFH276.

The primary objective of the Phase II study is to evaluate the efficacy of GFH276 in patients with RAS-mutant advanced pancreatic ductal adenocarcinoma (PDAC), advanced non-small cell lung cancer (NSCLC), advanced colorectal cancer (CRC), and other advanced solid tumors.

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Key information

Conditions

Cancer CRC (Colorectal Cancer) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms NSCLC Neoplasms Neoplasms by Site PDAC Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
  • Male or female ≥ 18 years old and ≤75 years old.
  • ECOG performance status of 0-1.
  • With a life expectancy of ≥3 moths
  • Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.
  • Adequate laboratory parameters during the screening period.

Exclusion criteria

  • Active brain metastases.
  • Prior treatment with a PAN-RAS inhibitor.
  • Palliative radiotherapy was completed within 14 days before the first dose.
  • Have poorly controlled or severe cardiovascular disease.
  • Subjects with active hepatitis B or active hepatitis C.
  • Known allergy to the study drug or its components.
  • Pregnant or lactating women.

Treatment and study plan

GFH276

Drug

GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

Primary outcomes

  1. Phase Ia:The incidence and severity of AEs and SAEs

    Time frame: 48 months

    The incidence and severity of AEs and SAEs

  2. Phase Ia:The incidence of DLT events

    Time frame: 21 days

    The incidence of DLT events

  3. Phase Ib:The incidence and severity of AEs and SAEs

    Time frame: 48 months

    The incidence and severity of AEs and SAEs

  4. Phase II:Overall response rate (ORR)

    Time frame: about 48 months

    Aassessed by investigators according to RECIST 1.1

  5. Efficacy endpoints

    Time frame: about 48 months

    Duration of response (DoR)

Secondary outcomes

  1. Peak Plasma Concentration(Cmax)

    Time frame: about 48 months

  2. DCR

    Time frame: about 48 months

    he percentage of patients who achieved CR, PR and SD

Study contacts

Contact information is provided by the study sponsor or research team.

peng, PM

CONTACT

[email protected]

021-50781198

Sponsors and collaborators

Lead sponsor

Genfleet Therapeutics (Shanghai) Inc.

Industry

Registry information

Official study title

A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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